A study to evaluate the impact of glucose variability

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic diseases

• Registration Number: KCT0004320
• Lead Sponsor: Korea University Ansan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-28
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

° Patients with type 2 diabetes aged 19 to 80 years
° Those who will be treated with the following medicines among patients who are receiving or are scheduled to initiate insulin multiple daily injections (MDI)
Type and product name of insulin
- Basal insulin: Levemir, Lantus, Tresiba, Toujeo
- Prandial insulin: NovoRapid, Fiasp, Humalog, Apidra
- Mixed insulin : Ryzodeg
° Hypoglycemic agents other than insulin
- Metformin, Thiazolidinedione (Pioglitazone, Lobeglitazone, Rosiglitazone), Sulfonylurea (Glimepiride, Gliclazide, Glipizide, Glibenclamide), Meglitinide (Repaglinide, Nateglinide, Mitiglinide), DPP4 inhibitor (Sitagliptin, Linagliptin, Gemigliptin, Vildagliptin, Saxagliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin), GLP-1 agonist (Exenatide, Lixisenatide, Liraglutide, Exenatide LAR, Albiglutide, Dulaglutide), SGLT-2 inhibitor (Dapagliflozin, Empagliflozin, Ipragliflozin), a-glucosidase Inhibitor (Acarbose, Voglibose)
° Fasting C-peptide level measured at the hospital in the past 2 years is 0.4-3.0ng/mL.

Exclusion Criteria

Those who fall under any of the following criteria
° Insulin pump users
° Those who have been hospitalized for HHS (hyperglycemia hyperosmolar syndrome), DKA (Diabetic ketoacidosis), acute myocardial infarction, or stroke in the past 3 months
° Stage 4 or 5 of chronic renal disease (< eGFR 30)
° Patients with hepatic failure (AST or ALT = 2.5 times the upper normal limit) or symptomatic heart failure with pulmonary oedema
° Those who are currently receiving anticancer therapy, radiation therapy, and targeted therapy
° Those who are currently receiving the following medicines that may affect blood glucose
- Steroid, immunosuppressive agents (cyclosporine, tacrolimus, and sirolimus), nicotinic acid =1500mg/day, systemic isotretinoin, and anti-obesity agents (liraglutide, orlistat, phentermine, phendimetrazine, mazindol)
- Route of steroid administration: Oral administration and intravenous injection and joint injection are excluded from the study (A nasal spray or inhaler at maintenance dose may be used in this study)
° Patients with uncontrolled hypertension (SBP =160 mmHg or DBP =100 mmHg)
° Pregnant or lactating women
° Those who are determined to be not eligible for this study in the judgment of the investigator

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
odds ratio for hypoglycemia during continuous glucose monitoring

Secondary Outcome Measures

Name	Time	Method
Odds ratio between glucose variability and diabetes complications (diabetic retinopathy, renal disease, and neuropathy);Odds ratio between glucose variability and cardiovascular disorders;Correlation between glucose variability and insulin resistance;Correlation between glucose variability and heart rate variability;Correlation between glucose variability and muscle mass;correlation between glucose variability and blood pressure variability.;correlation between glucose variability and heart function.